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Process Engineer - III - P3 (DE)
[17023]
Upstream/Downstream, Process Engineer
Join a growing Biotech Process Engineering team and drive the evaluation, implementation, and qualification of innovative equipment, technologies, and processes for biologics development and clinical manufacturing. This is a fully on-site role supporting GMP operations and next-generation manufacturing initiatives. Project title: Process Engineer - III - P3 Type of employment: Payroll Industry: Biotech Skills: Upstream/Downstream,Process Engineer Project start: 02.03.2026 Project duration: 2 years Location: Lucerne, Switzerland Tasks: ·Lead and coach cross-functional teams in implementing new technologies for GMP batch and continuous manufacturing of Drug Substance and Drug Product. ·Coordinate activities with global partners (US, Ireland) to introduce new processes and digital solutions. ·Act as a Change Champion to support innovation, digitization, and improved ways of working. ·Serve as SME for evaluating and qualifying new equipment, software, and instruments. ·Prepare URS, risk assessments, sampling plans, batch records, qualification documents, and SOPs/WIs. ·Support GMP compliance, quality assurance, and knowledge management across interdisciplinary teams. ·Harmonize technologies between batch and continuous manufacturing platforms. Qualifications: ·5+ years of experience in pharmaceutical or biotech manufacturing. ·Project management experience with cross-functional teams. ·Knowledge of upstream and downstream biologics unit operations. ·Strong analytical and problem-solving skills. ·Business-fluent English (C1) and German (B1). ·3+ years working with quality systems; auditing experience is a plus. ·Familiarity with DeltaV, SIPAT, and automation in manufacturing. ·Understanding of CPPs, CQAs, and equipment qualification principles. ·Experience in biologics drug substance operations, analytical testing, or process development. ·Proactive mindset and ability to work independently and collaboratively.
- Lead and coach cross-functional teams in implementing new technologies for GMP batch and continuous manufacturing of Drug Substance and Drug Product.
- Coordinate activities with global partners (US, Ireland) to introduce new processes and digital solutions.
- Act as a Change Champion to support innovation, digitization, and improved ways of working.
- Serve as SME for evaluating and qualifying new equipment, software, and instruments.
- Prepare URS, risk assessments, sampling plans, batch records, qualification documents, and SOPs/WIs.
- Support GMP compliance, quality assurance, and knowledge management across interdisciplinary teams.
- Harmonize technologies between batch and continuous manufacturing platforms.
- 5+ years of experience in pharmaceutical or biotech manufacturing.
- Project management experience with cross-functional teams.
- Knowledge of upstream and downstream biologics unit operations.
- Strong analytical and problem-solving skills.
- Business-fluent English (C1) and German (B1).
- 3+ years working with quality systems; auditing experience is a plus.
- Familiarity with DeltaV, SIPAT, and automation in manufacturing.
- Understanding of CPPs, CQAs, and equipment qualification principles.
- Experience in biologics drug substance operations, analytical testing, or process development.
- Proactive mindset and ability to work independently and collaboratively.
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